Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)

This study is currently recruiting participants.
Verified January 2014 by Medtronic Atrial Fibrillation Solutions
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01456949
First received: October 19, 2011
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.


Condition Intervention Phase
Paroxysmal Atrial Fibrillation (PAF)
Device: Medtronic Arctic Front® Cardiac CryoAblation System
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)

Resource links provided by NLM:


Further study details as provided by Medtronic Atrial Fibrillation Solutions:

Primary Outcome Measures:
  • Effectiveness [ Time Frame: Through 36 months ] [ Designated as safety issue: No ]

    Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).

    Chronic treatment failure is defined as:

    • Documented atrial fibrillation lasting longer than 30 seconds (outside the 90 day blanking period) OR
    • Intervention for atrial fibrillation (except for repeat cryoablation during the 90 day blanking period)

  • Safety [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Demonstrate safety (through 12 months) of Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the rate of subjects experiencing Cryoablation Procedure Events (CPEs) with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).


Secondary Outcome Measures:
  • Chronic Safety [ Time Frame: Annually, through 5 years ] [ Designated as safety issue: Yes ]
    Freedom from Major Atrial Fibrillation Event (MAFE): A MAFE is a serious adverse event (SAE) which has not been categorized as a cryoablation procedure event.

  • Chronic Effectiveness [ Time Frame: Annually, through 5 years ] [ Designated as safety issue: No ]

    Freedom from chronic treatment failure, defined as:

    • Documented atrial fibrillation lasting longer than 30 seconds (outside the 90 day blanking period) OR
    • Intervention for atrial fibrillation (except for repeat cryoablation during the 90 day blanking period)


Estimated Enrollment: 400
Study Start Date: May 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Medtronic Arctic Front® Cardiac CryoAblation System
    Cardiac cryoablation to isolate the pulmonary veins using the Arctic Front® CryoAblation System, with point ablation using the Freezor® Max as needed.
    Other Names:
    • Medtronic CryoCath CryoConsole
    • Arctic Front® Cardiac CryoAblation Catheter
    • Freezor® MAX Cardiac CryoAblation Catheter
Detailed Description:

Safety and effectiveness will be evaluated against pre-specified performance criteria as determined by the sponsor and FDA. The criteria set in this study have been previously used to demonstrate safety and effectiveness in cryoablation and radio-frequency ablation for the treatment of paroxysmal atrial fibrillation.

The analyses of the primary effectiveness objective will take place once all the subjects with a study cryoablation procedure attempt have reached 36 months of follow-up post-cryoablation procedure. The analysis of the primary safety objective will take place once all the subjects with a study cryoablation procedure attempt have reached 12 months of follow-up post-cryoablation procedure. The analyses for the secondary objectives will take place once all subjects with a study cryoablation attempt have reached 60 months of follow-up post-cryoablation procedure.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Documented PAF:

    • Diagnosis of paroxysmal atrial fibrillation (PAF), AND
    • 2 or more episodes of AF during the 3 months preceding the consent Date, AND
    • At least 1 episode of AF documented with a tracing within 12 months preceding the consent date.
  2. Age 18 years or older
  3. Failure for the treatment of AF (effectiveness or intolerance) of at least one membrane active AAD for rhythm control.

Exclusion Criteria:

  1. Any previous left atrial (LA) ablation (except permissible retreatment subjects)
  2. Any previous LA surgery
  3. Current intracardiac thrombus (can be treated after thrombus is resolved)
  4. Presence of any pulmonary vein stents
  5. Presence of any pre-existing pulmonary vein stenosis
  6. Pre-existing hemidiaphragmatic paralysis
  7. Anteroposterior LA diameter > 5.5 cm by TTE
  8. Presence of any cardiac valve prosthesis
  9. Clinically significant mitral valve regurgitation or stenosis
  10. Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date
  11. Unstable angina
  12. Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date
  13. Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
  14. NYHA class III or IV congestive heart failure
  15. Left ventricular ejection fraction (LVEF) < 40%
  16. 2º (Type II) or 3º atrioventricular block
  17. Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
  18. Brugada syndrome
  19. Long QT syndrome
  20. Arrhythmogenic right ventricular dysplasia
  21. Sarcoidosis
  22. Hypertrophic cardiomyopathy
  23. Known cryoglobulinemia
  24. Uncontrolled hyperthyroidism
  25. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.
  26. Any woman known to be pregnant
  27. Life expectancy less than one (1) year
  28. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic
  29. Unwilling or unable to comply fully with study procedures and followup
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456949

  Hide Study Locations
Locations
United States, California
Good Samaritan Hospital Recruiting
San Jose, California, United States, 95124
Contact: Lori Henry, NP    408-879-5904    Lori.Henry@hcahealthcare.com   
Principal Investigator: Matthew Levy, MD         
United States, Colorado
Colorado Heart and Vascular Recruiting
Denver, Colorado, United States, 80204
Contact: Dana Long    303-629-2241    dlong@chvpc.com   
Principal Investigator: Thomas Svinarich, MD         
United States, Florida
Daytona Heart Group Recruiting
Daytona Beach, Florida, United States, 32114
Contact: Nancy Mather    386-258-8722    nmather52@gmail.com   
Principal Investigator: Hanscy Seide, MD         
Broward General Medical Center Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Debra Ayer, MSN    954-355-5563    dayer@browardhealth.org   
Principal Investigator: Ahmed Osman, MD         
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Tempa Curry    352-273-9079    tempa.curry@medicine.ufl.edu   
Principal Investigator: William Miles, MD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Deanna Hill, RN    404-727-4939    dmhill@emory.edu   
Principal Investigator: Michael Lloyd, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Anna Huskin, RN BSN    312-695-4067    ahuskin@nmh.org   
Principal Investigator: Bradley Knight, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mai Doan    617-726-0280      
Principal Investigator: Moussa Mansour, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Deborah Manuelian    617-732-5087    dmanuelian@partners.org   
Principal Investigator: Roy John, MD         
United States, Minnesota
St. Mary's Hospital - Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55902
Contact: Kristi Monahan, RN    507-255-6676    Monahan.Kristi@mayo.edu   
Principal Investigator: Douglas Packer, MD         
HealthEast St. Joseph's Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Joyce Riestenberg-Smith, RN    651-471-2671    jmriestenberg@healtheast.org   
Principal Investigator: Stuart Adler, MD         
United States, Nebraska
Bryan LGH Recruiting
Lincoln, Nebraska, United States, 68506
Contact: Cheryl Orosco, RN BS    402-483-3291    Cheryl.orosco@bryanheart.com   
Principal Investigator: Andrew Merliss, MD         
United States, Ohio
Bethesda North Hospital l TriHealth Hatton Institute Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Nancy Firsich, RN    513-865-1148    nancy_firsich@trihealth.com   
Principal Investigator: Gaurang Gandhi, MD         
United States, Oklahoma
Oklahoma Heart Institute Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Jolene Durham, RN    918-579-4939    jdurham@hillcrest.com   
Principal Investigator: Craig Cameron, MD         
United States, Pennsylvania
Capital Cardiovascular Associates Recruiting
Camp Hill, Pennsylvania, United States, 17011
Contact: Joanna Stuck, RN BSN    717-724-6450 ext 1367    joanna.stuck@hsh.org   
Principal Investigator: Safwat Gassis, MD         
Doylestown Cardiology Associates Recruiting
Doylestown, Pennsylvania, United States, 18901
Contact: Linda Schwarz, RN    215-933-0053    lschwarz@cbspecialists.com   
Principal Investigator: Robert Sangrigoli, MD         
Lancaster Heart & Stroke Recruiting
Lancaster, Pennsylvania, United States, 17602
Contact: Holly Snyder, CMA    717-290-6681 ext 207    hsnyder@lancasterheart.org   
Principal Investigator: Douglas Gohn, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jennifer Dueweke, RN BSN    412-367-6321    duewekeje@upmc.edu   
Principal Investigator: Sandeep Jain, MD         
United States, South Carolina
Columbia Heart Clinic Recruiting
Columbia, South Carolina, United States, 29203
Contact: Michelle Hamman, RN    803-744-5369    mhamman@columbia-heart.com   
Principal Investigator: H.Wade Collins III, MD         
United States, Tennessee
Stern Cardiovascular Recruiting
Germantown, Tennessee, United States, 38138
Contact: Susan Bass    901-271-1000    Susan.Bass@sterncardio.com   
Principal Investigator: Eric Johnson, MD         
Saint Thomas Research Institute Recruiting
Nashville, Tennessee, United States, 37205
Contact: Danielle Buchanan, RN    615-329-5144 ext 242    Danielle.Buchanan@baptisthospital.com   
Contact: Jane Jackson, MSN    615-222-3024    jfjackson@stthomas.org   
Principal Investigator: James Baker, MD         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Dana Red, RN    214-590-5015    Dana.Red@UTSouthwestern.edu   
Principal Investigator: Richard Wu, MD         
Saint Luke's Episcopal Hospital - Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Aline Barzilla    832-355-3710    abarzilla@sleh.com   
Principal Investigator: John Seger, MD         
Baylor Research Institute Recruiting
Plano, Texas, United States, 75093
Contact: Gamar Rahimova    972-964-0363    Gamar.Rahimova@baylorhealth.edu   
Principal Investigator: Brian DeVille, MD         
United States, Virginia
Inova Fairfax Hospital Recruiting
Fairfax, Virginia, United States, 22031
Contact: Patricia Neblett, RN    703-776-3228    patricia.neblett@inova.org   
Principal Investigator: Marc Wish, MD         
Canada, Alberta
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Sylvia Martin    780-735-4489    reoffice@ualberta.ca   
Principal Investigator: Evan Lockwood, MD         
Canada, British Columbia
Victoria Cardiac Arrhythmia Trials Inc Recruiting
Victoria, British Columbia, Canada
Contact: Fritha Munday, RN    250-595-0400    mbastell@catrials.org   
Principal Investigator: Paul Novak, MD         
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada
Contact: Evelyne Naas    514-376-3330 ext 3309    evelyne.naas@icm-mhi.org   
Principal Investigator: Marc Dubuc, MD         
Hôpital du Sacre Coeur de Montreal Recruiting
Montreal, Quebec, Canada
Contact: Ann Langlois, MS    514-338-2222    A-Langlois@crhsc.rtss.qc.ca   
Principal Investigator: Giuliano Becker, MD         
McGill University Health Centre Recruiting
Montreal, Quebec, Canada
Contact: Fiorella Rafti, BPharm PhD    514-934-1934 ext 42926      
Principal Investigator: Vidal Essebag, MD         
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec Recruiting
Quebec, Canada
Contact: Francine Hainse, RN    418-656-8711 ext 5828    francine.hainse@criucpq.ulaval.ca   
Principal Investigator: Jean Champagne, MD         
Sponsors and Collaborators
Medtronic Atrial Fibrillation Solutions
Investigators
Principal Investigator: Bradley P. Knight, MD, FACC, FHRS Northwestern Memorial Hospital
  More Information

No publications provided

Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT01456949     History of Changes
Other Study ID Numbers: STOP AF PAS
Study First Received: October 19, 2011
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Medtronic Atrial Fibrillation Solutions:
Atrial fibrillation (AF)
Paroxysmal atrial fibrillation (PAF)
Arrythmias
Cardiac Arrythmias
Cardiac ablation
Cryoablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014